Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Complications
研究概览
简要总结
Patients with gastric gastrointestinal stromal tumors will receive robotic resection.
详细描述
Gastrointestinal stromal tumors are the most common stromal tumors of the digestive tract. Approximately 60% of tumors develop in the stomach.Before, patients with gastric gastrointestinal stromal tumors would receive open or laparoscopic surgery. However, gastrointestinal stromal tumors located at special sites, such as cardia, were hardly treated. Recently, the robot was used to remove gastric gastrointestinal stromal tumors. In this study, the robot will be used to remove gastric gastrointestinal stromal tumors. Then, we will evaluate the effect of robotic gastric gastrointestinal stromal tumors resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requirements of informed consent and assent of participant, parent or legal guardian as applicable.
- •Patients with gastric gastrointestinal stromal tumors scheduled for robotic resection and between the age of 18 and 80 years old without considering sex.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Participants can follow the visit plan.
排除标准
- •Patients certified by a doctor that doesn't fit to participate in this study.
- •Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function > II (NYHA) patients, patients received coronary artery bypass grafting (CABG) recently, and patients with severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110mmHg).
- •Patients with gastrointestinal stromal tumor with distant metastasis.
- •Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance < 25 ml/min).
- •Patients with gastrointestinal operations and complicated abdominal operations.
- •Patients with severe malnutrition (albumin≤30g/L, weight loss in half a year>10%, Subjective Global Assessment (SGA) classification C, body mass index <18, Hb<70g/L).
- •Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants).
- •Patients participated other subjects 3 months before this subject.
- •Sponsors or researchers directly involved in the testing or their family members.
研究组 & 干预措施
The robot group
Patients undergo robotic gastric gastrointestinal stromal tumors resection.
干预措施: Robotic gastric gastrointestinal stromal tumors resection (Procedure)
结局指标
主要结局
Complications
时间窗: 1 month
Intraoperative and postoperative complications
次要结局
- Blood loss(1 day)
- Operative time(1 day)
- Resection style(1 day)
- Postoperative length of stay(1 month)
- Inflammation level(1 month)
- Nutritional status(6 months)
- Body composition(6 months)
研究者
JIANG Zhi-Wei
Vice director of Research Institute of General Surgery
Jinling Hospital, China